Int Urogynecol J DOI 10.1007/s00192-015-2738-1
ORIGINAL ARTICLE
Successful use of ring pessary with support for advanced pelvic organ prolapse Jing Ding 1 & Chun Chen 1 & Xiao-chen Song 1 & Lei Zhang 1 & Mou Deng 1 & Lan Zhu 1
Received: 29 January 2015 / Accepted: 5 May 2015 # The International Urogynecological Association 2015
Abstract Introduction and hypothesis Support pessaries are not recommended for patients with advanced prolapse. This study aimed to explore the efficacy of the ring pessary with support for the treatment of advanced pelvic organ prolapse (POP). Methods We conducted this prospective study on pessary fittings performed between November 2013 and September 2014 at the Department of Obstetrics and Gynecology, Peking Union Medical College Hospital (PUMCH), Beijing. A total of 109 patients with stage III or IV POP completed a detailed history. A successful fitting was defined as the continued use of the device for over 3 months from the initial fitting. Data were analyzed with the Wilcoxon rank-sum test, independent sample t tests, continuity correction χ2 tests, and Fisher’s exact test. Results A total of 74.3 % (81/109) of the patients were successfully fitted with the ring pessary with support at the initial visit. Among those women with a successful initial fitting, the failure rate was less than 10 % (8/81) at 3 months. Furthermore, 82.7 % (67/81) of the patients were able to manage the pessary by themselves. Seven patients experienced vaginal erosion. There was no association of prolapse stage and the predominant prolapse compartment with pessary trial outcome. The average vaginal length of the patients with successful pessary use was 7.58 cm.
* Lan Zhu [email protected] 1
Departments of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, No.1 ShuaiFu Road, Dongcheng District, Beijing, People’s Republic of China
Conclusions The ring pessary with support was successfully fitted in patients with advanced POP with a high success rate and few complications. Older patients were more likely to prefer the ring pessary with support due to its convenient use.
Keywords Ring pessary with support . Successfully . Advanced pelvic organ prolapse
Introduction Pelvic organ prolapse (POP) is a chronic pelvic floor disorder with a high prevalence among older women [1, 2]. Treatment for POP includes both surgical and nonsurgical options. Pessary use is an excellent conservative treatment option for some patients with POP. A survey conducted by the American Urogynecologic Society reported that nearly two thirds of physicians would choose the vaginal pessary over surgery as the first-line treatment for this condition [3]. Pessaries can be categorized into the following two types: support and space-occupying. The ring and other types of support pessaries are typically recommended for stage I and stage II prolapse and have the benefits of convenience and comfort [4]. In contrast, the Gellhorn and other types of space-occupying pessaries are often used to treat advanced prolapse cases [5]. However, the Gellhorn pessary is difficult for patients to remove and reinsert. In clinical practice, we have found that the ring pessary with support (Fig. 1) can be successfully utilized in patients with all stages of prolapse. Therefore, this study was designed to explore the efficacy of the ring pessary with support for the treatment of advanced POP.
Int Urogynecol J
Materials and methods
1 week for a follow-up examination. Another visit was then routinely scheduled for 4 weeks after the initial fitting. At each visit, patients were asked about any symptoms, such as vaginal bleeding, abnormal vaginal discharge, pain or discomfort, extrusion of the pessary, new-onset urinary incontinence, or problems with defecation. Examination with a vaginal speculum was performed after pessary removal to check for ulceration or other abnormalities. Patients with ulceration or vaginal bleeding underwent a 2-week pessary-free rest period and were advised to use topical estrogen cream. The pessary was reinserted after healing had occurred. The patients who discontinued pessary use returned for a discussion of surgical options, if desired. The number of fitting attempts and each woman’s subjective reason for discontinuation were carefully recorded. Further follow-up visits were scheduled on a 3- to 6month basis.
Study participants
Statistical analyses
A total of 109 patients (age range 49–85 years) with symptomatic POP (stages III and IV) were counseled for treatment options at the Center of Obstetrics and Gynecology, Peking Union Medical College Hospital (PUMCH), Beijing, between November 2013 and September 2014. All of the patients chose pessary use from the three options that were offered, which also included expectant therapy with pelvic floor muscle exercises and surgical treatment. This study was approved by the Ethics Committee of the PUMCH (number s-671).
We calculated the mean and standard deviation for continuous variables. Independent t tests were used to compare continuous variables between groups. Continuity correction tests, Wilcoxon rank-sum tests, and Fisher’s exact test were used to compare categorical variables as appropriate. A P value of ≤0.05 was considered to be statistically significant. SPSS v.19.0 (IBM Corp, Armonk, NY, USA) was used to perform statistical analyses.
Fig. 1 The ring pessary with support
Results Study design Baseline and historic data and physical examination findings were recorded. The patients were staged according to the Pelvic Organ Prolapse Quantification system (POP-Q) [6]. All of the patients were under the care of one experienced urogynecologist. Vaginal estrogen (Ovestin estriol cream) was not routinely prescribed before pessary fitting unless the patient had a vaginal ulcer. A ring pessary with support (CooperSurgical, Trumbull, CT, USA) was typically used for the initial fitting, followed by a Gellhorn. In general, the largest pessary that was comfortable for the patient was used. Those patients in whom a pessary was found to fit comfortably were asked to ambulate and perform Valsalva maneuvers while they were in the office. Those who felt comfortable were taught how to manage the device, which included removing, cleaning, and replacing it on a regular basis. All of the patients were advised to remove and clean the pessary before going to bed and to reinsert it the following morning at least once a week [5]. On the same day, the patients were prescribed a topical estrogen cream to protect the local vaginal epithelium from erosion. The type and size of the chosen vaginal pessary were also recorded. Successfully fitted patients returned after
A total of 109 patients with advanced symptomatic POP agreed to participate in this pessary trial. After the trial, 81 patients [81/109 (74.3 %)] were able to use the ring pessary with support. Another 28 patients [28/109 (25.7 %)] used the Gellhorn pessary. Therefore, we analyzed the characteristics of the 81 patients who used the ring pessary with support. The median age was 70 years (range 49–85 years), and the median parity was 2 (range 0–8). Nearly all the patients [80/81 (98.8 %)] were postmenopausal, and none had undergone hormonal treatment. More than half of the patients [44/81 (54.3 %)] had concomitant medical diseases, such as diabetes mellitus and/or hypertension. Only 2 patients [2/81 (2.5 %)] had a previous history of surgery for prolapse or hysterectomy. A total of 82.7 % (67/81) of the patients were able to manage the pessary by themselves. The median genital hiatus (gh) was 4.91 cm. The median total vaginal length (tvl) was 7.54 cm, resulting in a gh to tvl ratio of 0.65. None of the patients in this study switched to a larger pessary size within the follow-up period. Nine [9/81 (11.1 %)] patients had stage IV POP, and the remaining patients [72/81 (88.9 %)] had stage III POP. Four different size ring pessaries with support (1, 2, 3, and 4) were
Int Urogynecol J
used for the successful pessary fittings in this study. The proportion of patients who utilized a size 2 ring pessary with support [29/81 (35.8 %)] or size 3 [34/81 (42 %)] was higher than that for the other sizes. The median follow-up time was 8 months (range 3–13 months). The ring pessary with support was fitted in 81 patients at the initial visit. Pessary use was continued by 77 [77/109 (70.6 %)] patients at 1 week, 76 [76/ 109 (69.7 %)] patients at 1 month, and 73 [73/109 (67 %)] patients at 3 months. Eight patients discontinued pessary use at 3 months. Most failures [4/8 (50 %)] occurred within 1 week after the initial use of the device. The reasons for ceasing pessary use were as follows: feelings of discomfort and pressure (n=3), a desire for surgical treatment of the condition (n= 3), extrusion of the pessary during daily activities (n=1), and bothersome de novo stress urinary incontinence (SUI) (n=1). After discontinuing pessary use, half of these patients opted for surgery; for the other half, the device was removed without further treatment. However, a higher continuation rate [73/81 (90.1 %)] was achieved among the patients with successful fittings (81patients) (Figs. 2 and 3). The changes in prolapse and urinary symptoms after 3 months of pessary use were obvious among women with advanced POP who had a successful trial of a ring pessary with support. At baseline, the two most common prolapse symptoms were bulging [66/73 (90.4 %)] and pelvic pressure [47/73 (64.4 %)]. Each woman had at least one of these symptoms. Both prolapse symptoms improved significantly with pessary use; bulging particularly improved, with the incidence decreasing from 66/73 (90.4 %) to 17/73 (23.3 %). After using the pessary, 49 patients could not feel a bulge, and another 17
Fig. 2 Study flowchart
9
9 Size 1 Size 2
34
29
Size 3 Size 4
Fig. 3 The proportion of pessaries after the fitting trial
patients felt only a slight bulge when performing Valsalva maneuvers, but this did not affect their usual activities. The percentage of patients experiencing pelvic pressure decreased from 64.4 to 13.7 %. Regarding urinary symptoms at baseline, 63.0 % (46/73) reported voiding difficulty, 53.4 % (39/73) reported urge urinary incontinence, and 42.5 % (31/73) reported SUI. The symptom of splinting to void was less common, occurring in 19/73 patients (26.0 %). More than half of the patients with urinary symptoms experienced an improvement from baseline to 3 months. Voiding difficulty improved in 97.8 % (45/46) of the patients, splinting improved in 100 % (19/19), urge urinary incontinence improved in 76.9 % (30/ 39), and SUI improved in 58.1 % (18/31). We did not identify significant differences between the patients with and without previous stress incontinence or constipation or increased gravidity (P>0.05). De novo SUI was not associated with pessary failure. There were no significant differences in the stage of prolapse in the anterior, posterior, or
Int Urogynecol J
apical compartments between patients successfully fitted with a pessary and those who failed to be fitted. In addition, there was no difference in the predominant prolapse compartment between those with successful and unsuccessful fittings (Tables 1 and 2). Adverse events were evaluated in the patients with successful fittings. The most common adverse event was
Table 1 Patient characteristics in successful and unsuccessful pessary fitting groups
vaginal discharge, which was reported by 32 patients. Pain or discomfort was reported by 14 women. Excoriation or bleeding was observed in seven women. Among the 42 patients with no preexisting SUI, 6 [6/42 (14.3 %)] developed new-onset SUI. However, all of the patients reported a mild degree of SUI that could be managed by pelvic floor muscle exercises.
Characteristic
Successful (n=73)
Unsuccessful (n=8)
P value
Age, years
70.08±7.63
70.25±5.97
0.952a
Gravidity, median (range)
3 (0–8)
2 (2-5)
0.266b
Parity, median (range)
2(0-8)
2(1-3)
BMI, kg/m2, n
0.601b 0.706c
≤25
45
4
>25
28
4 1.000c
Medical problems, n No
33
4
Yes
40
4 1.000d
Lumbar disc herniation, n No
58
6
Yes
15
2 0.189c
Previous surgical history of prolapse or hysterectomy, n No
72
7
Yes
1
1 1.000c
Smoking, n No
69
8
Past/current
4
0 0.376d
Largest baby>8 lbs, n No
67
6
Yes
6
2 0.253c
Constipation, n No
46
3
Yes
27
5 0.385a
Manage, n Independently
59
8
With help from caregivers
14
0 0.376d
De novo stress incontinence, n No
67
6
Yes
6
2 1.000c
Previous urgency, n No
34
4
Yes
39
4
gh, cm, average (range)
4.93 (3–6)
4.75 (4–6)
0.496a
tvl, cm, average (range)
7.58 (5–10)
7.25 (6–9)
0.367a
gh/tvl
0.66
0.65
0.970a
BMI body mass index, gh genital hiatus, tvl total vaginal length a
Independent sample t test
b
Wilcoxon rank-sum test
c
Fisher’s exact text
d
Continuity correction χ2 test
Int Urogynecol J Table 2 Prolapse severity and predominant location of support loss with successful and unsuccessful pessary usage
Successful, n
33 7
Fisher’s exact test Continuity correction χ2 test
Discussion Ring pessaries with or without support are the most common types of pessary, and the ring pessary with support can be successfully utilized in patients with advanced stage prolapse. Although it is theoretically recommended only for patients with early stage POP, most of the patients in this study with advanced stage POP were fitted successfully with this device at 3 months. Nearly all of the prolapse symptoms (bulge and pressure) and urinary symptoms (voiding difficulty and splinting) were resolved after 3 months. Major complications, such as impaction [7] and urinary, rectal, and genital complications (including fistula and fecal impaction) [8], typically occur because of neglect (i.e., failure to regularly remove the pessary). In the present study, none of the women presented with major complications. Pessary use also prevented the progression of pelvic relaxation. These findings will be valuable to clinicians deciding on which type of pessary to order for a gynecological patient. The ring pessary with support is easy to utilize and remove; thus, it is typically used for the initial fitting in patients with POP at any stage.
3 1 1b
Stage IV Stage of posterior prolapse Stage III Stage IV Predominant compartment of support loss Anterior wall Apex Anterior wall-apex Complete eversion
b
P value 0.556a
Stage of apical prolapse Stage III Stage IV Stage of anterior prolapse Stage III
a
Unsuccessful, n
60
6
8
1 1a
3 3
2 1 0.067a
30 2 34 7
4 0 1 3
treatment might influence treatment choice [3, 12–14]. All treatment options should be discussed, and patients should actively participate in the treatment decision-making process. All of the patients in this study selected pessary use from three treatment options, which may be a reason for its high success rate. The current literature indicates that younger patients are more likely to choose surgery over pessary use [12, 15]. Thus, older women are more likely to continue to use this device than younger women [16]. The median age of the patients in our study was 70 years, which may have contributed to the high continuation rate. Considering these factors, younger patients who are likely to desire surgery because of an increased tolerance of surgical stress compared with older women may be discouraged by clinicians from undergoing prolonged pessary trials. We also prescribed vaginal estrogen cream in this study to maintain a healthy vaginal epithelium and to prevent erosion. Patients with a history of breast cancer or those who declined estrogen cream were offered a lubricant. The ring pessary with support is easy for patients to remove and reinsert. More than 80 % of the patients were able to manage the pessary by themselves. The patients encouraged, communicated with, and exchanged experiences with each other. These stated reasons may have contributed to our high success rate.
Reasons for the high success rate In this study, of the 109 consecutive women with symptomatic stage III or IV POP, 67 % were successfully fitted with a ring pessary with support at 3 months. Three other studies have evaluated pessary fitting; these previous studies reported successful fitting rates ranging from 56 to 64 % [9–11], which are slightly lower than our rate of 67 %. Fitting success may depend upon preconceived patient ideas, and both beliefs and attitudes regarding the etiology and success of pessary
Risk factors for discontinuation Studies have reported conflicting data regarding the clinical predictors of successful and unsuccessful fittings [13, 15–18], and the reasons for early discontinuation are unclear. It has been suggested by other authors that previous prolapse surgery or hysterectomy narrows the upper vaginal diameter, making it difficult to retain a pessary [19, 20]. It is likely that
Int Urogynecol J
a short vaginal length and a narrow vaginal apex act in concert, interfering with pessary retention in the midportion of the vagina. However, in our study, only two patients had previously undergone a hysterectomy; thus, this small number of patients may not be adequate to support this correlation. One multicenter study reported that the average vaginal length of patients who are successfully fitted with a pessary is 9.6 cm [21]. Patients with a tvl of less than 8 cm may be counseled that a successful pessary fitting is unlikely [22]. However, we found that the average vaginal length of the patients with successful fittings was 7.58 cm and that there was no difference in vaginal length between those with successful and failed fittings. This discrepancy in results is explained by dissimilar average vaginal length and width of the patients in our study compared with those reported in studies performed on patients from other countries. Therefore, results from previous studies might not be suitable for comparison. In addition, previous studies may have had different reasons for pessary failure. The reasons for failure in our study were always subjective (discomfort or a desire for surgery) rather than objective (the pessary fell out). Therefore, the tvl was similar between the success and failure groups. Rectocele is associated with weakening of the rectovaginal fascia; the posterior side of the vaginal wall then lacks the structure necessary to retain the pessary [23]. However, in our study, only five patients had stage III rectocele, and four patients had stage IV rectocele; thus, this small number of patients may not be adequate to support this correlation. In contrast, cystocele is associated with attenuation of the pubocervical fascia; however, the pubic bone at the anterior side of the vagina may provide structural support for the pessary [23]. The limitations of our study include the fact that our study population only included patients assessed at one center. In addition, although pessary use may decrease with time, we did not perform long-term follow-ups.
References 1.
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3.
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5.
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Conclusion Our study does not support the manufacturer’s recommendations that ring pessaries are only suitable for women with stages I and II prolapse or that Gellhorn or other spaceoccupying pessaries should be used in women with stages III and IV prolapse. This information is useful for counseling women with POP and for deciding on which type of pessary should be used for treatment.
13.
14.
15.
16.
Acknowledgments We thank all of the patients for agreeing to participate in our study. Conflicts of interest None.
17.
DeLancey JOL (2005) The hidden epidemic of pelvic floor dysfunction: achievable goals for improved prevention and treatment. Am J Obstet Gynecol 192:1488–1495. doi:10. 1016/j.ajog.2005.02.028 Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spimo C, Whitehead WE, Wu J, Brody DJ et al (2008) Prevalence of symptomatic pelvic floor disorders in US women. JAMA 300: 1311–1316. doi:10.1001/jama.300.11.1311 Cundiff GW, Weidner AC, Visco AG, Bump RC, Addision WA (2000) A survey of pessary use by members of the American Urogynecologic Society. Obstet Gynecol 95:931–935. doi:10. 1016/S0029-7844(00)00788-2 Jones KA, Harmanli OZ (2010) Pessary use in pelvic organ prolapse and urinary incontinence. Rev Obstet Gynecol 3:3–9. doi:10. 3909/riog0110 Weber AM, Richter HE (2005) Pelvic organ prolapse. Obstet Gynecol 106:615–634. doi:10.1097/01.AOG.0000175832. 13266.bb Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JOL, Klarskov P, Shull BL, Smith ARB (1996) The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 175:10–17. doi:10.1016/S00029378(96)70243-0 Fernando RJ, Sultan AH, Thakar R, Jeyanthan K (2007) Management of the neglected vaginal ring pessary. Int Urogynecol J Pelvic Floor Dysfunct 18:117–119. doi:10.1007/ s00192-006-0089-7 Arias BE, Ridgeway B, Barber MD (2008) Complications of neglected vaginal pessaries: case presentation and literature review. Int Urogynecol J Pelvic Floor Dysfunct 19:1173–1178. doi:10. 1007/s00192-008-0574-2 Wu V, Farrell SA, Baskett TF, Flowerdew G (1997) A simplified protocol for pessary management. Obstet Gynecol 90:990–994. doi:10.1016/S0029-7844(97)00481-X Sulak PJ, Kuehl TJ, Shull BL (1993) Vaginal pessaries and their use in pelvic relaxation. J Reprod Med 38:919–923. doi:10.1097/ 0006254-199404000-00018 Handa VL, Jones M (2002) Do pessaries prevent the progression of pelvic organ prolapse? Int Urogynecol J Pelvic Floor Dysfunct 13: 349–352. doi:10.1007/s001920200078 Kapoor DS, Thakar R, Sultan AH, Oliver R (2009) Conservative versus surgical management of prolapse: what dictates patient choice? Int Urogynecol J Pelvic Floor Dysfunct 20:1157–1161. doi:10.1007/s00192-009-0930-x Brincat C, Kenton K, Pat Fitzgerald M, Brubaker L (2004) Sexual activity predicts continued pessary use. Am J Obstet Gynecol 191: 198–200. doi:10.1016/j.ajog.2004.03.083 Heit M, Rosenquist C, Culligan P, Graham C, Murphy M, Shott S (2003) Predicting treatment choice for patients with pelvic organ prolapse. Obstet Gynecol 101:1279–1284. doi:10.1016/S00297844(03)00359-4 Powers K, Lazarou G, Wang A, Lacombe J, Bensigner G, Greston WM, Mikhail MS (2006) Pessary use in advanced pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct 17:160–164. doi:10.1007/s00192-005-1311-8 Clemons JL, Aguilar VC, Tillinghast TA, Jackson ND, Myers DL (2004) Risk factors associated with an unsuccessful pessary fitting trial in women with pelvic organ prolapse. Am J Obstet Gynecol 190:345–350. doi:10.1016/j.ajog.2003.08.034 Nguyen JN, Jones CR (2005) Pessary treatment of pelvic relaxation: factors affecting successful fitting and continued use. J Wound Ostomy Continence Nurs 32:255–261
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Maito JM, Quam ZA, Craig E, Danner KA, Rogers RG (2006) Predictors of successful pessary fitting and continued use in a nurse-midwifery pessary clinic. J Midwifery Womens Health 51: 78–84. doi:10.1016/j.jmwh.2005.09.003 Mutone MF, Terry C, Hale DS, Benson JT (2005) Factors which influence the short-term success of pessary management of pelvic organ prolapse. Am J Obstet Gynecol 193:89–94. doi:10.1016/j. ajog.2004.12.012 Fernando RJ, Thakar R, Sultan AH, Shah SM, Jones PW (2006) Effect of vaginal pessaries on symptoms associated with pelvic organ prolapse. Obstet Gynecol 108:93–99. doi:10.1097/01.AOG. 0000222903.38684.cc
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Nager CW, Richter HE, Nygaard L, Paraiso MF, Wu JM, Kenton K, Atnip SD, Spino C et al (2009) Incontinence pessaries: size, POPQ measures, and successful fitting. Int Urogynecol J Pelvic Floor Dysfunct 20:1023–1028. doi:10. 1007/s00192-009-0866-1 Markle D, Skoczylas L, Goldsmith C, Noblett K (2011) Patient characteristics associated with a successful pessary fitting. Female Pelvic Med Reconstr Surg 17:249–252. doi:10.1097/SPV. 0b013e31822f00ae Yamada T, Matsubara S (2011) Rectocele, but not cystocele, may predict unsuccessful pessary fitting. J Obstet Gynaecol 31:441–442. doi:10.3109/01443615.2011.577253
ORIGINAL ARTICLE
Successful use of ring pessary with support for advanced pelvic organ prolapse Jing Ding 1 & Chun Chen 1 & Xiao-chen Song 1 & Lei Zhang 1 & Mou Deng 1 & Lan Zhu 1
Received: 29 January 2015 / Accepted: 5 May 2015 # The International Urogynecological Association 2015
Abstract Introduction and hypothesis Support pessaries are not recommended for patients with advanced prolapse. This study aimed to explore the efficacy of the ring pessary with support for the treatment of advanced pelvic organ prolapse (POP). Methods We conducted this prospective study on pessary fittings performed between November 2013 and September 2014 at the Department of Obstetrics and Gynecology, Peking Union Medical College Hospital (PUMCH), Beijing. A total of 109 patients with stage III or IV POP completed a detailed history. A successful fitting was defined as the continued use of the device for over 3 months from the initial fitting. Data were analyzed with the Wilcoxon rank-sum test, independent sample t tests, continuity correction χ2 tests, and Fisher’s exact test. Results A total of 74.3 % (81/109) of the patients were successfully fitted with the ring pessary with support at the initial visit. Among those women with a successful initial fitting, the failure rate was less than 10 % (8/81) at 3 months. Furthermore, 82.7 % (67/81) of the patients were able to manage the pessary by themselves. Seven patients experienced vaginal erosion. There was no association of prolapse stage and the predominant prolapse compartment with pessary trial outcome. The average vaginal length of the patients with successful pessary use was 7.58 cm.
* Lan Zhu [email protected] 1
Departments of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, No.1 ShuaiFu Road, Dongcheng District, Beijing, People’s Republic of China
Conclusions The ring pessary with support was successfully fitted in patients with advanced POP with a high success rate and few complications. Older patients were more likely to prefer the ring pessary with support due to its convenient use.
Keywords Ring pessary with support . Successfully . Advanced pelvic organ prolapse
Introduction Pelvic organ prolapse (POP) is a chronic pelvic floor disorder with a high prevalence among older women [1, 2]. Treatment for POP includes both surgical and nonsurgical options. Pessary use is an excellent conservative treatment option for some patients with POP. A survey conducted by the American Urogynecologic Society reported that nearly two thirds of physicians would choose the vaginal pessary over surgery as the first-line treatment for this condition [3]. Pessaries can be categorized into the following two types: support and space-occupying. The ring and other types of support pessaries are typically recommended for stage I and stage II prolapse and have the benefits of convenience and comfort [4]. In contrast, the Gellhorn and other types of space-occupying pessaries are often used to treat advanced prolapse cases [5]. However, the Gellhorn pessary is difficult for patients to remove and reinsert. In clinical practice, we have found that the ring pessary with support (Fig. 1) can be successfully utilized in patients with all stages of prolapse. Therefore, this study was designed to explore the efficacy of the ring pessary with support for the treatment of advanced POP.
Int Urogynecol J
Materials and methods
1 week for a follow-up examination. Another visit was then routinely scheduled for 4 weeks after the initial fitting. At each visit, patients were asked about any symptoms, such as vaginal bleeding, abnormal vaginal discharge, pain or discomfort, extrusion of the pessary, new-onset urinary incontinence, or problems with defecation. Examination with a vaginal speculum was performed after pessary removal to check for ulceration or other abnormalities. Patients with ulceration or vaginal bleeding underwent a 2-week pessary-free rest period and were advised to use topical estrogen cream. The pessary was reinserted after healing had occurred. The patients who discontinued pessary use returned for a discussion of surgical options, if desired. The number of fitting attempts and each woman’s subjective reason for discontinuation were carefully recorded. Further follow-up visits were scheduled on a 3- to 6month basis.
Study participants
Statistical analyses
A total of 109 patients (age range 49–85 years) with symptomatic POP (stages III and IV) were counseled for treatment options at the Center of Obstetrics and Gynecology, Peking Union Medical College Hospital (PUMCH), Beijing, between November 2013 and September 2014. All of the patients chose pessary use from the three options that were offered, which also included expectant therapy with pelvic floor muscle exercises and surgical treatment. This study was approved by the Ethics Committee of the PUMCH (number s-671).
We calculated the mean and standard deviation for continuous variables. Independent t tests were used to compare continuous variables between groups. Continuity correction tests, Wilcoxon rank-sum tests, and Fisher’s exact test were used to compare categorical variables as appropriate. A P value of ≤0.05 was considered to be statistically significant. SPSS v.19.0 (IBM Corp, Armonk, NY, USA) was used to perform statistical analyses.
Fig. 1 The ring pessary with support
Results Study design Baseline and historic data and physical examination findings were recorded. The patients were staged according to the Pelvic Organ Prolapse Quantification system (POP-Q) [6]. All of the patients were under the care of one experienced urogynecologist. Vaginal estrogen (Ovestin estriol cream) was not routinely prescribed before pessary fitting unless the patient had a vaginal ulcer. A ring pessary with support (CooperSurgical, Trumbull, CT, USA) was typically used for the initial fitting, followed by a Gellhorn. In general, the largest pessary that was comfortable for the patient was used. Those patients in whom a pessary was found to fit comfortably were asked to ambulate and perform Valsalva maneuvers while they were in the office. Those who felt comfortable were taught how to manage the device, which included removing, cleaning, and replacing it on a regular basis. All of the patients were advised to remove and clean the pessary before going to bed and to reinsert it the following morning at least once a week [5]. On the same day, the patients were prescribed a topical estrogen cream to protect the local vaginal epithelium from erosion. The type and size of the chosen vaginal pessary were also recorded. Successfully fitted patients returned after
A total of 109 patients with advanced symptomatic POP agreed to participate in this pessary trial. After the trial, 81 patients [81/109 (74.3 %)] were able to use the ring pessary with support. Another 28 patients [28/109 (25.7 %)] used the Gellhorn pessary. Therefore, we analyzed the characteristics of the 81 patients who used the ring pessary with support. The median age was 70 years (range 49–85 years), and the median parity was 2 (range 0–8). Nearly all the patients [80/81 (98.8 %)] were postmenopausal, and none had undergone hormonal treatment. More than half of the patients [44/81 (54.3 %)] had concomitant medical diseases, such as diabetes mellitus and/or hypertension. Only 2 patients [2/81 (2.5 %)] had a previous history of surgery for prolapse or hysterectomy. A total of 82.7 % (67/81) of the patients were able to manage the pessary by themselves. The median genital hiatus (gh) was 4.91 cm. The median total vaginal length (tvl) was 7.54 cm, resulting in a gh to tvl ratio of 0.65. None of the patients in this study switched to a larger pessary size within the follow-up period. Nine [9/81 (11.1 %)] patients had stage IV POP, and the remaining patients [72/81 (88.9 %)] had stage III POP. Four different size ring pessaries with support (1, 2, 3, and 4) were
Int Urogynecol J
used for the successful pessary fittings in this study. The proportion of patients who utilized a size 2 ring pessary with support [29/81 (35.8 %)] or size 3 [34/81 (42 %)] was higher than that for the other sizes. The median follow-up time was 8 months (range 3–13 months). The ring pessary with support was fitted in 81 patients at the initial visit. Pessary use was continued by 77 [77/109 (70.6 %)] patients at 1 week, 76 [76/ 109 (69.7 %)] patients at 1 month, and 73 [73/109 (67 %)] patients at 3 months. Eight patients discontinued pessary use at 3 months. Most failures [4/8 (50 %)] occurred within 1 week after the initial use of the device. The reasons for ceasing pessary use were as follows: feelings of discomfort and pressure (n=3), a desire for surgical treatment of the condition (n= 3), extrusion of the pessary during daily activities (n=1), and bothersome de novo stress urinary incontinence (SUI) (n=1). After discontinuing pessary use, half of these patients opted for surgery; for the other half, the device was removed without further treatment. However, a higher continuation rate [73/81 (90.1 %)] was achieved among the patients with successful fittings (81patients) (Figs. 2 and 3). The changes in prolapse and urinary symptoms after 3 months of pessary use were obvious among women with advanced POP who had a successful trial of a ring pessary with support. At baseline, the two most common prolapse symptoms were bulging [66/73 (90.4 %)] and pelvic pressure [47/73 (64.4 %)]. Each woman had at least one of these symptoms. Both prolapse symptoms improved significantly with pessary use; bulging particularly improved, with the incidence decreasing from 66/73 (90.4 %) to 17/73 (23.3 %). After using the pessary, 49 patients could not feel a bulge, and another 17
Fig. 2 Study flowchart
9
9 Size 1 Size 2
34
29
Size 3 Size 4
Fig. 3 The proportion of pessaries after the fitting trial
patients felt only a slight bulge when performing Valsalva maneuvers, but this did not affect their usual activities. The percentage of patients experiencing pelvic pressure decreased from 64.4 to 13.7 %. Regarding urinary symptoms at baseline, 63.0 % (46/73) reported voiding difficulty, 53.4 % (39/73) reported urge urinary incontinence, and 42.5 % (31/73) reported SUI. The symptom of splinting to void was less common, occurring in 19/73 patients (26.0 %). More than half of the patients with urinary symptoms experienced an improvement from baseline to 3 months. Voiding difficulty improved in 97.8 % (45/46) of the patients, splinting improved in 100 % (19/19), urge urinary incontinence improved in 76.9 % (30/ 39), and SUI improved in 58.1 % (18/31). We did not identify significant differences between the patients with and without previous stress incontinence or constipation or increased gravidity (P>0.05). De novo SUI was not associated with pessary failure. There were no significant differences in the stage of prolapse in the anterior, posterior, or
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apical compartments between patients successfully fitted with a pessary and those who failed to be fitted. In addition, there was no difference in the predominant prolapse compartment between those with successful and unsuccessful fittings (Tables 1 and 2). Adverse events were evaluated in the patients with successful fittings. The most common adverse event was
Table 1 Patient characteristics in successful and unsuccessful pessary fitting groups
vaginal discharge, which was reported by 32 patients. Pain or discomfort was reported by 14 women. Excoriation or bleeding was observed in seven women. Among the 42 patients with no preexisting SUI, 6 [6/42 (14.3 %)] developed new-onset SUI. However, all of the patients reported a mild degree of SUI that could be managed by pelvic floor muscle exercises.
Characteristic
Successful (n=73)
Unsuccessful (n=8)
P value
Age, years
70.08±7.63
70.25±5.97
0.952a
Gravidity, median (range)
3 (0–8)
2 (2-5)
0.266b
Parity, median (range)
2(0-8)
2(1-3)
BMI, kg/m2, n
0.601b 0.706c
≤25
45
4
>25
28
4 1.000c
Medical problems, n No
33
4
Yes
40
4 1.000d
Lumbar disc herniation, n No
58
6
Yes
15
2 0.189c
Previous surgical history of prolapse or hysterectomy, n No
72
7
Yes
1
1 1.000c
Smoking, n No
69
8
Past/current
4
0 0.376d
Largest baby>8 lbs, n No
67
6
Yes
6
2 0.253c
Constipation, n No
46
3
Yes
27
5 0.385a
Manage, n Independently
59
8
With help from caregivers
14
0 0.376d
De novo stress incontinence, n No
67
6
Yes
6
2 1.000c
Previous urgency, n No
34
4
Yes
39
4
gh, cm, average (range)
4.93 (3–6)
4.75 (4–6)
0.496a
tvl, cm, average (range)
7.58 (5–10)
7.25 (6–9)
0.367a
gh/tvl
0.66
0.65
0.970a
BMI body mass index, gh genital hiatus, tvl total vaginal length a
Independent sample t test
b
Wilcoxon rank-sum test
c
Fisher’s exact text
d
Continuity correction χ2 test
Int Urogynecol J Table 2 Prolapse severity and predominant location of support loss with successful and unsuccessful pessary usage
Successful, n
33 7
Fisher’s exact test Continuity correction χ2 test
Discussion Ring pessaries with or without support are the most common types of pessary, and the ring pessary with support can be successfully utilized in patients with advanced stage prolapse. Although it is theoretically recommended only for patients with early stage POP, most of the patients in this study with advanced stage POP were fitted successfully with this device at 3 months. Nearly all of the prolapse symptoms (bulge and pressure) and urinary symptoms (voiding difficulty and splinting) were resolved after 3 months. Major complications, such as impaction [7] and urinary, rectal, and genital complications (including fistula and fecal impaction) [8], typically occur because of neglect (i.e., failure to regularly remove the pessary). In the present study, none of the women presented with major complications. Pessary use also prevented the progression of pelvic relaxation. These findings will be valuable to clinicians deciding on which type of pessary to order for a gynecological patient. The ring pessary with support is easy to utilize and remove; thus, it is typically used for the initial fitting in patients with POP at any stage.
3 1 1b
Stage IV Stage of posterior prolapse Stage III Stage IV Predominant compartment of support loss Anterior wall Apex Anterior wall-apex Complete eversion
b
P value 0.556a
Stage of apical prolapse Stage III Stage IV Stage of anterior prolapse Stage III
a
Unsuccessful, n
60
6
8
1 1a
3 3
2 1 0.067a
30 2 34 7
4 0 1 3
treatment might influence treatment choice [3, 12–14]. All treatment options should be discussed, and patients should actively participate in the treatment decision-making process. All of the patients in this study selected pessary use from three treatment options, which may be a reason for its high success rate. The current literature indicates that younger patients are more likely to choose surgery over pessary use [12, 15]. Thus, older women are more likely to continue to use this device than younger women [16]. The median age of the patients in our study was 70 years, which may have contributed to the high continuation rate. Considering these factors, younger patients who are likely to desire surgery because of an increased tolerance of surgical stress compared with older women may be discouraged by clinicians from undergoing prolonged pessary trials. We also prescribed vaginal estrogen cream in this study to maintain a healthy vaginal epithelium and to prevent erosion. Patients with a history of breast cancer or those who declined estrogen cream were offered a lubricant. The ring pessary with support is easy for patients to remove and reinsert. More than 80 % of the patients were able to manage the pessary by themselves. The patients encouraged, communicated with, and exchanged experiences with each other. These stated reasons may have contributed to our high success rate.
Reasons for the high success rate In this study, of the 109 consecutive women with symptomatic stage III or IV POP, 67 % were successfully fitted with a ring pessary with support at 3 months. Three other studies have evaluated pessary fitting; these previous studies reported successful fitting rates ranging from 56 to 64 % [9–11], which are slightly lower than our rate of 67 %. Fitting success may depend upon preconceived patient ideas, and both beliefs and attitudes regarding the etiology and success of pessary
Risk factors for discontinuation Studies have reported conflicting data regarding the clinical predictors of successful and unsuccessful fittings [13, 15–18], and the reasons for early discontinuation are unclear. It has been suggested by other authors that previous prolapse surgery or hysterectomy narrows the upper vaginal diameter, making it difficult to retain a pessary [19, 20]. It is likely that
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a short vaginal length and a narrow vaginal apex act in concert, interfering with pessary retention in the midportion of the vagina. However, in our study, only two patients had previously undergone a hysterectomy; thus, this small number of patients may not be adequate to support this correlation. One multicenter study reported that the average vaginal length of patients who are successfully fitted with a pessary is 9.6 cm [21]. Patients with a tvl of less than 8 cm may be counseled that a successful pessary fitting is unlikely [22]. However, we found that the average vaginal length of the patients with successful fittings was 7.58 cm and that there was no difference in vaginal length between those with successful and failed fittings. This discrepancy in results is explained by dissimilar average vaginal length and width of the patients in our study compared with those reported in studies performed on patients from other countries. Therefore, results from previous studies might not be suitable for comparison. In addition, previous studies may have had different reasons for pessary failure. The reasons for failure in our study were always subjective (discomfort or a desire for surgery) rather than objective (the pessary fell out). Therefore, the tvl was similar between the success and failure groups. Rectocele is associated with weakening of the rectovaginal fascia; the posterior side of the vaginal wall then lacks the structure necessary to retain the pessary [23]. However, in our study, only five patients had stage III rectocele, and four patients had stage IV rectocele; thus, this small number of patients may not be adequate to support this correlation. In contrast, cystocele is associated with attenuation of the pubocervical fascia; however, the pubic bone at the anterior side of the vagina may provide structural support for the pessary [23]. The limitations of our study include the fact that our study population only included patients assessed at one center. In addition, although pessary use may decrease with time, we did not perform long-term follow-ups.
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2.
3.
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5.
6.
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12.
Conclusion Our study does not support the manufacturer’s recommendations that ring pessaries are only suitable for women with stages I and II prolapse or that Gellhorn or other spaceoccupying pessaries should be used in women with stages III and IV prolapse. This information is useful for counseling women with POP and for deciding on which type of pessary should be used for treatment.
13.
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15.
16.
Acknowledgments We thank all of the patients for agreeing to participate in our study. Conflicts of interest None.
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